D-0853-2022 Class II Terminated
FDA drug recall D-0853-2022 was initiated by Dr. Reddy's Laboratories, Inc. on Apr 15, 2022 and is designated Class II. Reason for recall: Failed Dissolution Specifications The recall status is terminated (terminated Nov 7, 2023). Affected quantity: 252 Blister Packs.
Recall Details
- Product Type
- Drugs
- Report Date
- May 11, 2022
- Initiation Date
- Apr 15, 2022
- Termination Date
- Nov 7, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 252 Blister Packs
Product Description
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs of 10 Tablets each, 100 Tablets per blister pack, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, NDC 43598-561-78.
Reason for Recall
Failed Dissolution Specifications
Distribution Pattern
OH
Code Information
Lot #: T2000645, Exp 07/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0853-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026